A Novel Trans-Septal Cannula for Wearable Extracorporeal Membrane Oxygenation: In Vitro Hemodynamic Evaluation and Placement Feasibility

Extracorporeal membrane oxygenation (ECMO) supports patients with end-stage heart and lung disease awaiting transplantation. In pulmonary hypertension, veno-arterial ECMO (VA-ECMO) is common but linked to vascular complications and limited mobility, hindering pre-transplant rehabilitation. To overcome these challenges, we developed the BioArt-Lung (BAL) cannula-a trans-septal, dual-lumen, self-expanding device enabling cardiopulmonary support through single venous access, avoiding groin cannulation. Bench tests compared BAL with three dual-lumen cannulas, assessing pressures and transluminal flow using water and blood analogs at 0° and 120° angulation. Placement feasibility was evaluated on a three-dimensional (3D)-printed heart model, and right atrial unloading was tested via inferior vena cava perfusion. Pressure and flow remained consistent across fluids and angulations ( p = ns). BioArtificial Lung exhibited significantly less admission lumen depression than Avalon 27Fr ( p < 0.0001). Trans-septal insertion was smooth, and complete right atrial unloading occurred at 2 L/min flow. BioArtificial Lung demonstrated effective hemodynamics and feasible trans-septal placement via superior vena cava access. These results support further in vivo studies to assess biocompatibility and long-term outcome.